- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00789737
Welchol as Monotherapy for Type 2 Diabetes Mellitus
January 24, 2014 updated by: Daiichi Sankyo, Inc.
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of Welchol as Monotherapy for Type 2 Diabetes Mellitus
The current study investigates Welchol as monotherapy to improve glycemic control in subjects with Type 2 Diabetes Mellitus not adequately controlled with diet and exercise alone.
The study will evaluate if Welchol monotherapy for Type 2 Diabetes Mellitus will be safe, well tolerated and efficacious.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
357
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35294
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Birmingham, Alabama, United States, 35216
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Montgomery, Alabama, United States, 36117
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Muscle Shoals, Alabama, United States, 35662
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Arizona
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Green Valley, Arizona, United States, 85614
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Mesa, Arizona, United States, 85203
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Mesa, Arizona, United States, 85210
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Tucson, Arizona, United States, 85741
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Tucson, Arizona, United States, 85723
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Tucson, Arizona, United States, 85705
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Arkansas
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Searcy, Arkansas, United States, 72143
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California
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Buena Park, California, United States, 90620
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Burbank, California, United States, 91505
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Chula Vista, California, United States, 91910
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Garden Grove, California, United States, 92844
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Huntington Park, California, United States, 90255
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Irvine, California, United States, 92618
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La Mirada, California, United States, 90638
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Lincoln, California, United States, 95648
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Lomita, California, United States, 90717
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Los Angeles, California, United States, 90015
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Los Angeles, California, United States, 90057
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Los Gatos, California, United States, 95032
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Santa Ana, California, United States, 92701
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Tustin, California, United States, 92780
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Walnut creek, California, United States, 94598
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Florida
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Brooksville, Florida, United States, 34601
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Coral Gables, Florida, United States, 33134
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DeLand, Florida, United States, 32720
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Delray Beach, Florida, United States, 33484
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Gulf Breeze, Florida, United States, 32561
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Hialeah, Florida, United States, 33012
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Jacksonville, Florida, United States, 32223
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Kissimmee, Florida, United States, 34741
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Miami, Florida, United States, 33175
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Miami, Florida, United States, 33169
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Miami, Florida, United States, 33135
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New Port Richey, Florida, United States, 34652
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Ocala, Florida, United States, 34471
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Ormond Beach, Florida, United States, 32174
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Pembroke Pines, Florida, United States, 33026
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Vero Beach, Florida, United States, 32960
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Wellington, Florida, United States, 33449
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Winter Park, Florida, United States, 32789
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Georgia
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Decatur, Georgia, United States, 30035
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East Point, Georgia, United States, 30344
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Roswell, Georgia, United States, 30076
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Stockbridge, Georgia, United States, 30281
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Stone Mountain, Georgia, United States, 30083
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Idaho
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Nampa, Idaho, United States, 83686
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Illinois
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Chicago, Illinois, United States, 60607
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Indiana
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Evansville, Indiana, United States, 47714
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LaPorte, Indiana, United States, 46350
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South Bend, Indiana, United States, 46614
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Kentucky
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Crestview Hills, Kentucky, United States, 41017
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Louisiana
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Lafayette, Louisiana, United States, 70503
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Maryland
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Prince Frederick, Maryland, United States, 20678
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Silver Spring, Maryland, United States, 20910
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Massachusetts
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New Bedford, Massachusetts, United States, 02740
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Michigan
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Southfield, Michigan, United States, 48034
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Mississippi
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Port Gibson, Mississippi, United States, 39150
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Missouri
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St. Louis, Missouri, United States, 63128
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St. Louis, Missouri, United States, 63141
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Montana
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Billings, Montana, United States, 59101
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Nevada
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Las Vegas, Nevada, United States, 89123
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New Jersey
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Berlin, New Jersey, United States, 08009
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Clifton, New Jersey, United States, 07013
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Mine Hill, New Jersey, United States, 07803
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New York
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New Windsor, New York, United States, 12553
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North Massapequa, New York, United States, 11758-1802
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West Seneca, New York, United States, 14224
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North Carolina
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Lexington, North Carolina, United States, 27295
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Statesville, North Carolina, United States, 28625
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Wilmington, North Carolina, United States, 28401
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Ohio
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Cincinnati, Ohio, United States, 45219
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Cincinnati, Ohio, United States, 45227
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Cincinnati, Ohio, United States, 45245
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Cleveland, Ohio, United States, 44122
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Cuyahoga Falls, Ohio, United States, 44223
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Marion, Ohio, United States, 43302
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Munroe Falls, Ohio, United States, 44262
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Shaker Heights, Ohio, United States, 44120
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73103
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Oklahoma City, Oklahoma, United States, 73159
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Oregon
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Portland, Oregon, United States, 97220
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Pennsylvania
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Harrisburg, Pennsylvania, United States, 17112
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Jersey Shore, Pennsylvania, United States, 17740
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South Carolina
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Charleston, South Carolina, United States, 29414
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Charleston, South Carolina, United States, 29412
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Columbia, South Carolina, United States, 29201
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Greer, South Carolina, United States, 29651
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Texas
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Arlington, Texas, United States, 76012
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Dallas, Texas, United States, 75230
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Dallas, Texas, United States, 75235
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Fort Worth, Texas, United States, 76117
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Houston, Texas, United States, 77074
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Houston, Texas, United States, 77008
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Houston, Texas, United States, 77081
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Houston, Texas, United States, 77083
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San Antonio, Texas, United States, 78229
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Sugar Land, Texas, United States, 77479
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Tomball, Texas, United States, 77375
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Utah
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Salt Lake City, Utah, United States, 84107
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Salt Lake City, Utah, United States, 84102
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Virginia
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Manassas, Virginia, United States, 20110
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Salem, Virginia, United States, 24153
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Wisconsin
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Milwaukee, Wisconsin, United States, 53209
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or female subjects >= 18 years of age;
- Women of childbearing potential (WOCBP) must be using an adequate method of contraception as detailed in the protocol.
- Diagnosis of Type 2 Diabetes Mellitus;
- HbA1C >= 7.5% and =< 9.5 % at screening;
- Fasting C-peptide >0.5 ng/mL at screening;
- Drug naïve (no prior treatment with OAD) or having received no pharmacologic therapy for diabetes for the 3 month period prior to screening;
- Clinically stable in regards to medical conditions other than type 2 diabetes;
- Concomitant medications must be at stable doses for at least 30 days prior to enrollment, and are not anticipated to need adjustment during the study period; and
- Fasting glucose =< 240 mg/dL at randomization
Exclusion Criteria:
- A history of type 1 diabetes and/or a history of ketoacidosis;
- History of bowel obstruction;
- History of hypertriglyceridemia-induced pancreatitis;
- Fasting serum triglyceride concentrations >500 mg/dL;
- History of dysphagia, swallowing disorders, gastroparesis, other gastrointestinal (GI) motility disorders, or major GI surgery;
- History of insulin use of >= 2 weeks duration in the previous 3 months or a total of > 2 months of insulin therapy at any time prior to screening;
- Two or more fasting self-monitored blood glucose (SMBG) levels >240 mg/dL during the placebo lead-in period.
- Previous treatment with a bile acid sequestrant, including Welchol within the 3 months prior to screening;
- Body mass index (BMI) >40 kg/m2;
- Weight loss > 3% in prior 3 months; and
- LDL <60 mg/dL.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: placebo
|
placebo
|
Experimental: Welchol
Welchol 625mg tablets
|
Welchol 625mg tablets
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent Change in Hemoglobin A1c
Time Frame: 24 week
|
change in HbA1c from baseline to Week 24
|
24 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Fasting Plasma Glucose
Time Frame: from baseline to 24 weeks
|
to determine changes in Glycemic control after 24 weeks on therapy
|
from baseline to 24 weeks
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% Subjects With a Decrease in HbA1c of >= 0.7 Percentage Units
Time Frame: 24 weeks
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to determine the percentage of participants who experience a reduction in HbA1c of at least 0.7 percentage units at 24 weeks from baseline.
|
24 weeks
|
% Subjects Achieving an HbA1C Goal of <7.0
Time Frame: 24 weeks
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% Subjects achieving an HbA1C goal of <7.0 at 24 weeks
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24 weeks
|
% Subjects With a Decrease in FPG >=30 mg/dL
Time Frame: from baseline to 24 weeks
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% Subjects with a decrease in Fasting Plasma Glucose >=30 mg/dL from baseline to 24 weeks
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from baseline to 24 weeks
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Changes in Total Cholesterol [TC]
Time Frame: from baseline to 24 weeks
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To assess the effects of Welchol on changes in total cholesterol [TC]
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from baseline to 24 weeks
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Changes in Low Density Lipoprotein Cholesterol [LDL-C]
Time Frame: from baseline to 24 weeks
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To assess the effects of Welchol on changes in low density lipoprotein cholesterol [LDL-C]
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from baseline to 24 weeks
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Changes in High Density Lipoprotein Cholesterol [HDL-C]
Time Frame: from baseline to 24 weeks
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To assess the effects of Welchol on changes in high density lipoprotein cholesterol [HDL-C]
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from baseline to 24 weeks
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Changes in Non-HDL-C
Time Frame: from baseline to 24 weeks
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To assess the effects of Welchol on changes in non-HDL-C
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from baseline to 24 weeks
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Changes in Triglycerides [TG]
Time Frame: from baseline to 24 weeks
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To assess the effects of Welchol on changes in triglycerides [TG]
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from baseline to 24 weeks
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Changes in Apolipoprotein A-I (apoA-I)
Time Frame: from baseline to 24 weeks
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To assess the effects of Welchol on changes in apolipoprotein A-I (apoA-I)
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from baseline to 24 weeks
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Changes in Apolipoprotein B (apoB)
Time Frame: from baseline to 24 weeks
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To assess the effects of Welchol on changes in apolipoprotein B (apoB)
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from baseline to 24 weeks
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Change in Postprandial Plasma Glucose, 2 Hours After a Meal Tolerance Test
Time Frame: from baseline to 24 weeks
|
To assess the change from baseline on postprandial plasma glucose, 2 hours after a meal tolerance test
|
from baseline to 24 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2009
Primary Completion (Actual)
December 1, 2011
Study Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
November 10, 2008
First Submitted That Met QC Criteria
November 10, 2008
First Posted (Estimate)
November 13, 2008
Study Record Updates
Last Update Posted (Estimate)
February 27, 2014
Last Update Submitted That Met QC Criteria
January 24, 2014
Last Verified
January 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- WEL-305
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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